Safety and Efficacy of Campath in Nonmyeloablative Transplantation

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective of the low-dose transplant regimen must produce the following effects:

1. Suppression of the patient's immune system to prevent rejection of the donor cells;

2. Control of the lymphoma. The pretransplant regimen must suppress the lymphoma sufficiently to prevent marked progression of the tumor and allow time for the GVT effect to occur.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Alemtuzumab; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

Inclusion Criteria:

1. Up to 70 years of age (physiological).

2. Any histological subtype of lymphoid malignancies (those with CD20 negative disease will not receive Rituximab).

3. Patients in relapse with a partial remission or stable disease.

4. Patients who failed a prior autologous transplant are also eligible.

5. Patients must have a matched unrelated donor and no human leukocyte antigen (HLA) identical sibling is available. Point scale (PS)<2.

6. Patients are included even if they were previously exposed to Campath or Rituximab.

Exclusion Criteria:

1. Past history of anaphylaxis following exposure to rat- or mouse-derived COR-grafted humanized monoclonal antibodies.

2. Less than 4 weeks since prior chemotherapy counted from 1st day of treatment regimen.

3. Pregnancy or lactation.

4. HIV or HTLV-I positively.

5. Serum creatinine >1.6mg/dl or serum bilirubin >1.5mg/dl unless due to tumor.

6. Pulmonary function tests (PFTs) -OLCO<50%, cardiac EF <50% of predicted levels.

7. Patient with severe concomitant medical or psychiatric illness.